Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.
late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support. Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
134
Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
Equivalent volume of saline
King Salman Bin Abdulaziz Medical City
Madinah, Medina Region, Saudi Arabia
RECRUITINGKing Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
RECRUITINGDuration of respiratory support
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
Time frame: 28 days
Episodes of apnea
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Time frame: 28 gays
Failure of extubation
need of re-intubation within 72 h of extubation from mechanical ventilation
Time frame: 28 days
Duration of caffeine
Days of caffeine treatment
Time frame: 28 days
Length of hospital stay
days of hospital admission
Time frame: 28 days
Time to full enteral and oral feeding
days to reach full enteral feeds
Time frame: 28 days
Adverse effects of caffeine use
Tachycardia, irritability, feeding intolerance, hypertension
Time frame: 28 days
Caffeine withhold
Caffeine withhold for suspected side effects
Time frame: 28 days
Weight gain per day
Weight gain per day (gram)
Time frame: 28 days
Mortality
Death before hospital discharge
Time frame: 28 days
Readmission rate
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Time frame: 28 days
Days of apnea
Days of apnea
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.